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Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.

Condition or disease

Intervention/treatment

Phase

Cytomegalovirus RetinitisHIV Infections

Drug: Sevirumab

Phase 2

Detailed Description:

Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.

Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.

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Ages Eligible for Study:

13 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Concurrent Medication: Required:

Primary CMV treatment.

Patients must have:

AIDS.

Active CMV retinitis.

At least one photographable lesion of one-quarter or more optic disc area in size.

Undergoing primary treatment for CMV retinitis that is not contraindicated with MSL 109.